Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis

Osama O. Zaidat, Alicia C. Castonguay, Brian Fred Fitzsimmons, Britton Keith Woodward, Zhigang Wang, Monika Killer-Oberpfalzer, Ajay Wakhloo, Rishi Gupta, Howard Kirshner, Misha Eliasziw, J. Thomas Megerian, Sujith Shetty, Meg Yoklavich Guilhermier, Stanley Barnwell, Wade S. Smith, Daryl R. Gress

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.

Original languageEnglish (US)
Pages (from-to)1131-1139
Number of pages9
JournalJournal of Stroke and Cerebrovascular Diseases
Volume22
Issue number7
DOIs
StatePublished - Oct 2013

Fingerprint

Stents
Pathologic Constriction
Therapeutics
Stroke
Transient Ischemic Attack
Random Allocation
Anticoagulants
Patient Selection
Multicenter Studies
Ischemia
Clinical Trials
Safety
Population

Keywords

  • angioplasty
  • balloon-mounted stent
  • clinical trial
  • endovascular
  • intracranial stenosis
  • intracranial stent
  • ischemic stroke
  • PHAROS stent
  • stroke
  • transient ischemic attack
  • VISSIT
  • Vitesse stent

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery
  • Rehabilitation
  • Cardiology and Cardiovascular Medicine

Cite this

Zaidat, O. O., Castonguay, A. C., Fitzsimmons, B. F., Woodward, B. K., Wang, Z., Killer-Oberpfalzer, M., ... Gress, D. R. (2013). Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis. Journal of Stroke and Cerebrovascular Diseases, 22(7), 1131-1139. https://doi.org/10.1016/j.jstrokecerebrovasdis.2012.10.021

Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis. / Zaidat, Osama O.; Castonguay, Alicia C.; Fitzsimmons, Brian Fred; Woodward, Britton Keith; Wang, Zhigang; Killer-Oberpfalzer, Monika; Wakhloo, Ajay; Gupta, Rishi; Kirshner, Howard; Eliasziw, Misha; Thomas Megerian, J.; Shetty, Sujith; Yoklavich Guilhermier, Meg; Barnwell, Stanley; Smith, Wade S.; Gress, Daryl R.

In: Journal of Stroke and Cerebrovascular Diseases, Vol. 22, No. 7, 10.2013, p. 1131-1139.

Research output: Contribution to journalArticle

Zaidat, OO, Castonguay, AC, Fitzsimmons, BF, Woodward, BK, Wang, Z, Killer-Oberpfalzer, M, Wakhloo, A, Gupta, R, Kirshner, H, Eliasziw, M, Thomas Megerian, J, Shetty, S, Yoklavich Guilhermier, M, Barnwell, S, Smith, WS & Gress, DR 2013, 'Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis', Journal of Stroke and Cerebrovascular Diseases, vol. 22, no. 7, pp. 1131-1139. https://doi.org/10.1016/j.jstrokecerebrovasdis.2012.10.021
Zaidat, Osama O. ; Castonguay, Alicia C. ; Fitzsimmons, Brian Fred ; Woodward, Britton Keith ; Wang, Zhigang ; Killer-Oberpfalzer, Monika ; Wakhloo, Ajay ; Gupta, Rishi ; Kirshner, Howard ; Eliasziw, Misha ; Thomas Megerian, J. ; Shetty, Sujith ; Yoklavich Guilhermier, Meg ; Barnwell, Stanley ; Smith, Wade S. ; Gress, Daryl R. / Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis. In: Journal of Stroke and Cerebrovascular Diseases. 2013 ; Vol. 22, No. 7. pp. 1131-1139.
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abstract = "Background: Patients with high-grade symptomatic intracranial stenosis (≥70{\%}) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70{\%}) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.",
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AU - Zaidat, Osama O.

AU - Castonguay, Alicia C.

AU - Fitzsimmons, Brian Fred

AU - Woodward, Britton Keith

AU - Wang, Zhigang

AU - Killer-Oberpfalzer, Monika

AU - Wakhloo, Ajay

AU - Gupta, Rishi

AU - Kirshner, Howard

AU - Eliasziw, Misha

AU - Thomas Megerian, J.

AU - Shetty, Sujith

AU - Yoklavich Guilhermier, Meg

AU - Barnwell, Stanley

AU - Smith, Wade S.

AU - Gress, Daryl R.

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N2 - Background: Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.

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KW - transient ischemic attack

KW - VISSIT

KW - Vitesse stent

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